Chewable tablet containing lysine

ABSTRACT

A tablet with enhanced compliance by humans, in particular children and/or juveniles, comprising: (a) a vitamin; (b) lysine or a pharmaceutically acceptable salt thereof; (c) a sweetener; and (d) a pharmaceutically or dietetically acceptable carrier.

RELATED APPLICATIONS

Benefit under 35 U.S.C. § 119(e) of prior U.S. provisional applicationSer. No. 60/332,693, filed Nov. 14, 2001, is hereby claimed.

FIELD OF THE INVENTION

The present invention relates to a tablet with enhanced compliance byhumans, in particular children and/or juveniles comprising at least onevitamin, optionally at least one mineral, and lysine or apharmaceutically acceptable salt thereof.

BACKGROUND OF THE INVENTION

It is known that lysine as an essential amino acid enhances appetiteand, together with vitamin D₃, improves the absorption of calcium. Theprior art dealing with lysine as nutritional supplement may be bestillustrated by the following references: A. A. Albanese et al., NY StateJ. Med. 1955; 55, 3453-3456 describe lysine supplementation in infantfeeding. G. G. Graham et al., Am. J. Clin. Nutr. 1969; 22 (11),1459-1468 describe the effect of lysine enrichment of wheat flour forthe evaluation in infants. R. Civitelli et al., Nutrition 1992; 8 (6),400-405, disclose the metabolism of (L)-lysine and calcium in humans. P.Fürst, Nutrition 1993; 9 (1), 71-72 suggests (L)-lysine as a nutritionaltool in the prophylaxis and treatment of osteoporosis. N. W. Flodin, J.Am. Coll. Nutr. 1997; 16 (1), 7-21, reviews the metabolic roles, thepharmacology and the toxicology of lysine.

Accordingly, there is a need to provide humans, in particular childrenand/or juveniles, with lysine supplementation. However, children willhardly accept chewable tablets which contain effective amounts of lysinedue to its disgusting taste. The problem underlying the presentinvention was to provide a lysine containing chewable tablet which iswell accepted by children and/or juveniles.

SUMMARY OF THE INVENTION

The invention relates to a tablet with enhanced compliance by humanscomprising the following constituents:

-   -   (a) at least one vitamin,    -   (b) optionally at least one mineral,    -   (c) lysine or a pharmaceutically acceptable salt thereof,    -   (d) at least one sweetener and optionally at least one flavoring        agent having the capability of masking the disgusting flavor of        lysine,    -   (e) and a pharmaceutically or dietetically acceptable carrier.

Another aspect of the present invention is a method of improving thephysiological state of humans which method comprises administering aneffective amount of the tablet according to the present invention.

Furthermore, the invention relates to a method for the manufacture of atablet according to the present invention which method comprises mixingof the different components (a) to (e) and tabletting by directcompression.

DETAILED DESCRIPTION OF THE INVENTION

The invention relates in particular to tablets to be sucked or chewed bychildren and/or juveniles wherein the disgusting taste caused by lysineis masked.

Specifically the subject matter of this invention provides tabletsintended for the oral way, to be sucked or to be chewed, containing asactive ingredients lysine, one or more vitamins, and optionally one ormore minerals. Lysine is preferably provided in form of apharmaceutically acceptable salt, in particular as (L)-lysinemonohydrochloride. Most preferably the tablet comprises 10 mg to 100 mg,in particular about 50 mg of (L)-lysine monohydrochloride per unitdosage.

Preferably component (a) comprises at least one vitamin selected fromthe group consisting of retinol equivalents such as β-carotene orvitamin A, vitamin B such as vitamin B₁, vitamin B₂, vitamin B₆, orvitamin B₁₂, vitamin C, vitamin D such as vitamin D₃, vitamin E, folicacid, vitamin H, and vitamin PP.

The ranges of amounts of ingredients given hereinabove and hereinbelowrelate to the declared amount of said ingredients and includeappropriate stability overdosages.

Most preferably component (a) is a mixture of vitamins consistingessentially of 0.4 mg to 0.8 mg, in particular about 0.5 mg to 0.7 mg ofβ-carotene, 500 IU to 1500 IU, in particular about 700-1100 IU ofvitamin A palmitate, 0.3 mg to 1.0 mg, in particular about 0.4 mg to 0.6mg of vitamin B₁ nitrate, 0.3 mg to 1.0 mg, in particular about 0.5 mgto 0.7 mg of vitamin B₂, 0.3 mg to 1.0 mg, in particular about 0.5 mg to0.7 mg of vitamin B₆ hydrochloride, 0.4 μg to 1.0 μg, in particularabout 0.5 μg to 0.9 μg of vitamin B₁₂, 15 mg to 40 mg, in particularabout 20 mg to 30 mg of vitamin C, 100 IU to 300 IU, in particular about125 IU to 200 IU of vitamin D₃, 3.0 mg to 9.5 mg, in particular about4.0 mg to 6.5 mg of vitamin E acetate, 20 μg to 80 μg, in particularabout 40 μg to 70 μg of folic acid, 10 μg to 25 μg, in particular about14 μg to 21 μg of vitamin H, and 4 mg to 10 mg, in particular about 5 mgto 8 mg of vitamin PP per unit dosage.

Preferably component (b) comprises at least one mineral selected fromthe group consisting of manganese such as manganese (II) gluconate,copper such as copper (II) carbonate, calcium such as dicalciumphosphate anhydrous, iron such as ferrous (II) fumarate, zinc such aszinc oxide and magnesium such as magnesium oxide.

Most preferably component (b) is a mixture consisting essentially of 0.2mg to 0.8 mg, in particular about 0.4 mg to 0.6 mg of copper (II)carbonate, 150 mg to 300 mg, in particular about 200 mg to 250 mg ofdicalcium phosphate anhydrous, 8 mg to 20 mg, in particular about 11 mgto 14 mg of ferrous (II) fumarate, 4 mg to 9 mg, in particular about 6mg to 7 mg of zinc oxide and 12 mg to 28 mg, in particular about 18 mgto 21 mg of magnesium oxide per unit dosage.

Preferably component (d) contains at least one sweetener selected fromthe group consisting of calcium saccharinate, ammonium cyclamate,ammonium glycirhizinate, aspartame (N-L-α-aspartyl-L-phenylalanine1-methylester), glucose and glucitols such as inositol, mannitol,sorbitol or dulcitol and at least one flavoring agent selected from thegroup consisting of natural citrus or orange flavor and PROSWEET®, whichis a commercially available natural flavoring.

Most preferably component (d) consists essentially of 1.0 mg to 10.0 mg,in particular 4.0 mg to 8.0 mg of aspartame, 100.0 mg to 400.0 mg, inparticular 200.0 mg to 350.0 mg of glucose, 200 mg to 800 mg, inparticular 300 mg to 700 mg of sorbitol, 5.0 mg to 50.0 mg, inparticular 10.0 mg to 30.0 mg of natural orange flavor and 1.0 mg to10.0 mg, in particular 2.0 mg to 6.0 mg of PROSWEET® per unit dosage.

Preferably component (e) comprises at least one carrier selected fromthe group consisting of diluents, excipients, sticking agents, bulkagents, preservatives, colorants and other pharmaceutical or foodprocessing agents.

Among the suitable excipients or diluents, it may particularly be citedacidifying or buffering agents such as citric acid, urea, or glycine,bulk agents such or mannitol or sorbitol, adhering agents with low speedof dissolution such as alkyl cellulose, for example, methyl cellulose,ethylcellulose, hydroxypropyl cellulose, hydroxypropyl methyl celluloseor carboxy methyl cellulose or copolymers of methacrylic and acrylicacid; binding agents such as silicon dioxide, polyvinyl pyrrolidone,arabic gum, guar gum, adraganth gum, or karaya gum, lubricating agentssuch as magnesium stearate, inert diluents such as lactose, gelatin,starch, mono- or diglyceride fatty acids, edible fat, sodium aluminiumsilicate, hydrogenated vegetable oil, calcium carbonate, magnesiumphosphate, or calcium sulfate; skim milk powder, and sodium caseinate.

Among the suitable colorants, it may particularly be cited Turmericpowder (E100), Carmine powder (E120), β-carotene and Sunset Yellow(E110), Beetroot Red (E162), Erythrosine Red (E127), or a combination ofthese colorants.

Most preferred is a tablet which can be chewed or sucked with enhancedcompliance by children and/or juveniles, preferably at an age of 4 to16, in particular 6 to 14 years comprising the following constituents:

-   -   (a) a mixture of vitamins consisting essentially of 0.4 mg to        0.8 mg of β-carotene, 500 IU to 1500 IU of vitamin A palmitate,        0.3 mg to 1.0 mg of vitamin B₁ nitrate, 0.3 mg to 1.0 mg of        vitamin B₂, 0.3 mg to 1.0 mg of vitamin B₆ hydrochloride, 0.4 μg        to 1.0 μg of vitamin B₁₂, 15 mg to 40 mg of vitamin C, 100 IU to        300 IU of vitamin D₃, 3.0 mg to 9.5 mg of vitamin E acetate, 20        μg to 80 μg of folic acid, 10 μg to 25 μg of vitamin H, and 4 mg        to 10 mg of vitamin PP per unit dosage,    -   (b) a mixture of minerals consisting essentially of 0.2 mg to        0.8 mg of copper (II) carbonate, 150 mg to 300 mg of dicalcium        phosphate anhydrous, 8.0 mg to 20 mg of ferrous (II) fumarate, 4        mg to 9 mg of zinc oxide and 12 mg to 28 mg of magnesium oxide        per unit dosage,    -   (c) 10 mg to 100 mg of (L)-lysine monohydrochloride per unit        dosage,    -   (d) a mixture of sweeteners and flavoring agents consisting        essentially of 1.0 mg to 10.0 mg of aspartame, 5.0 mg to 50.0 mg        of glucose syrup, 200 mg to 800 mg of sorbitol, 5.0 mg to 50.0        mg of natural orange flavor and 1.0 mg to 10.0 mg of PROSWEET®        per unit dosage;    -   (e) a pharmaceutically or dietetically acceptable carrier,        wherein the complete dosage unit weighs 500 mg to 2000 mg.

Another aspect of the present invention resides in a method of improvingthe physiological state of humans, in particular improving thedevelopment and growth of children and/or juveniles, most preferably atan age of 4 to 16 years comprising administering orally an effectiveamount of a tablet comprising the following constituents to said humans:

-   -   (a) at least one vitamin,    -   (b) optionally at least one mineral,    -   (c) lysine or a pharmaceutically acceptable salt thereof,    -   (d) at least one sweetener and optionally at least one flavoring        agent having the capability of masking the disgusting flavor of        lysine, and    -   (e) a pharmaceutically or dietetically acceptable carrier.

This invention also relates to a process for preparing the tabletsaccording to this invention, which consists in the mixing or conjunctionof the active ingredients (a), (b) and (c) with the taste masking agent(d) and with one or several carriers (e) such as diluents, excipients,sticking agents, buffering agents, bulk agents, and/or lubricatingagents, to realize a pharmaceutical form suitable to be suckled orchewed, such as tablets, or lozenges. This production is obtainedaccording to the known methods of pharmaceutical technology.

The following examples are merely illustrative of the invention withoutlimiting it in any manner. EXAMPLE I Tablets to be Sucked ComponentFunction Declared amount/tablet [mg] Active Ingredients (a) + (c)(L)-lysine monohydrochioride essential amino acid 50.00 Betatab, 10%(E160a) vitamin 5.14 (0.514 β-Carotene) Vitamin A palmitate (500000IU/g) vitamin 1.43 (715 IU) Vitamin B₁ nitrate (thiamine mononitratevitamin 1.50 (0.50 Vit. B₁ nitrate) rocoat 33.3%) Vitamin B₂ (Riboflavinrocoat 33.3%) vitamin 1.65 (0.55 Vit. B₂) Vitamin B₆ hydrochloride(Pyridoxine vitamin 1.65 (0.55 Vit. B₆ hydrochloride rocoat 33.3%)hydrochloride) Vitamin B₁₂ (Cyanocobalamin 0.1%) vitamin 0.60 (0.60 10³Vit. B₁₂) Vitamin C (Ascorbic acid 90%) vitamin 24.44 (22.0 Vit. C)Vitamin D₃ (Cholecalciferol 100.000 IU/g) vitamin 1.50 (150 IU Vit. D₃)Vitamin E acetate (50% d,l-α-tocopherol vitamin 10.43 (5.215 Vit. Eacetate) acetate) Folic acid vitamin 0.05 Biotin vitamin 1.50 10³ (15.010³ Vit. H) Vitamin PP (Nicotinamide rocoat 33.3%) vitamin 18.0 (6.0Vit. PP) Minerals (b) Copper carbonate mineral 0.52 Dicalcium phosphateanhydrous mineral 220.64 Ferrous (II) fumarate (coated 60%) mineral12.68 Zinc oxide (coated 50%) mineral 6.25 Magnesium oxide, heavymineral 19.89 Taste mask (d) Aspartame powder sweetener 6.00 NaturalOrange Flavor flavor 22.00 Dextrose sweetener 275.00 PROSWEET ® flavor4.00 Sorbitol sweetener/carrier 597.44 Carrier (e) Citric acid acidifier50.00 Silicon dioxide, colloidal binder 14.00 Magnesium stearatelubricant 12.00 Hydrogenated vegetable oil diluent 25.00

Once the mixture of components (a), (b), (c) and (d) are perfectlyhomogenized, the carriers (e) are added thereto. The resulting powder isscreened then tableted by direct compression into tablets having adiameter of 16.0 mm, a thickness of 6.5 mm to 7.5 mm, a mean weight ofabout 1400 mg and a hardness of not more than 200 N.

These tablets show a good geometric stability. They swell into anexpanded form, practically equal to that of the starting tablet. Theyprogressively and completely release the active ingredients when incontact with saliva in the mouth.

EXAMPLE II Determination of the Acceptability of the Tablets Accordingto this Invention.

The acceptability is determined on a group of 144 healthy children (age6 to 14 years) which received a tablet which corresponds to the recipeof example 1 containing 50 mg (L)-lysine hydrochloride. Each childchewed this tablet until it has been completely consumed. The childrenare subsequently interviewed about the taste of the product. The sametest is then repeated using different multi-vitamin preparations (Prep Aand Prep B) presently on the market which do not contain lysine at all.The following results were obtained: Example Prep Prep 1 (%) A (%) B (%)Observation of behavior: calmly chews the tablet, it 52 63 36 seems totaste well Likeability of the taste: very good taste 33 45 18 good taste28 23 26 Sweetness of tablets: sweet enough, just right 70 76 68Sourness of tablets: too sour 29 18 39 not too sour 71 82 61 Feeling inthe mouth after chewing: good 76 80 58 not so good 24 20 42 Interest ineating again: very interested 20 32 11 quite interested 49 35 35

These results clearly show that the tablets according to the presentinvention despite the high content of (L)-lysine are in the same rangeof acceptability as Prep A, but are much more acceptable than Prep B.

1. A tablet comprising: (a) a vitamin; (b) lysine or a pharmaceuticallyacceptable salt thereof; (c) a sweetener; and (d) a pharmaceutically ordietetically acceptable carrier.
 2. The tablet according to claim 1,further comprising a mineral.
 3. The tablet according to claim 1,further comprising a flavoring agent capable of masking the flavor oflysine.
 4. The tablet according to claim 2, further comprising aflavoring agent capable of masking the flavor of lysine.
 5. The tabletaccording to claim 1, wherein the vitamin is selected from the groupconsisting of: β-carotene, vitamin A palmitate, vitamin B₁ nitrate,vitamin B₂, vitamin B₆ hydrochloride, vitamin B₁₂, vitamin C, vitaminD₃, vitamin E acetate, folic acid, vitamin H, and vitamin PP.
 6. Thetablet according to claim 2, wherein the vitamin is selected from thegroup consisting of: β-carotene, vitamin A palmitate, vitamin B₁nitrate, vitamin B₂, vitamin B₆ hydrochloride, vitamin B₁₂, vitamin C,vitamin D₃, vitamin E acetate, folic acid, vitamin H, and vitamin PP. 7.The tablet according to claim 3, wherein the vitamin is selected fromthe group consisting of: β-carotene, vitamin A palmitate, vitamin B₁nitrate, vitamin B₂, vitamin B₆ hydrochloride, vitamin B₁₂, vitamin C,vitamin D₃, vitamin E acetate, folic acid, vitamin H, and vitamin PP. 8.The tablet according to claim 4, wherein the vitamin is selected fromthe group consisting of: β-carotene, vitamin A palmitate, vitamin B₁nitrate, vitamin B₂, vitamin B₆ hydrochloride, vitamin B₁₂, vitamin C,vitamin D₃, vitamin E acetate, folic acid, vitamin H, and vitamin PP. 9.The tablet according to claim 1, wherein the vitamin is a mixture ofvitamins consisting essentially of: 0.4 mg to 0.8 mg of β-carotene, 500IU to 1500 IU of vitamin A palmitate, 0.3 mg to 1.0 mg of vitamin B₁nitrate, 0.3 mg to 1.0 mg of vitamin B₂, 0.3 mg to 1.0 mg of vitamin B₆hydrochloride, 0.4 μg to 1.0 μg of vitamin B₁₂, 15 mg to 40 mg ofvitamin C, 100 IU to 300 IU of vitamin D₃, 3.0 mg to 9.5 mg of vitamin Eacetate, 20 μg to 80 μg of folic acid, 10 μg to 25 μg of vitamin H, and4 mg to 10 mg of vitamin PP per unit dosage.
 10. The tablet according toclaim 2, wherein the vitamin is a mixture of vitamins consistingessentially of: 0.4 mg to 0.8 mg of β-carotene, 500 IU to 1500 IU ofvitamin A palmitate, 0.3 mg to 1.0 mg of vitamin B₁ nitrate, 0.3 mg to1.0 mg of vitamin B₂, 0.3 mg to 1.0 mg of vitamin B₆ hydrochloride, 0.4μg to 1.0 μg of vitamin B₁₂, 15 mg to 40 mg of vitamin C, 100 IU to 300IU of vitamin D₃, 3.0 mg to 9.5 mg of vitamin E acetate, 20 μg to 80 μgof folic acid, 10 μg to 25 μg of vitamin H, and 4 mg to 10 mg of vitaminPP per unit dosage.
 11. The tablet according to claim 3, wherein thevitamin is a mixture of vitamins consisting essentially of: 0.4 mg to0.8 mg of β-carotene, 500 IU to 1500 IU of vitamin A palmitate, 0.3 mgto 1.0 mg of vitamin B₁ nitrate, 0.3 mg to 1.0 mg of vitamin B₂, 0.3 mgto 1.0 mg of vitamin B₆ hydrochloride, 0.4 μg to 1.0 μg of vitamin B₁₂,15 mg to 40 mg of vitamin C, 100 IU to 300 IU of vitamin D₃, 3.0 mg to9.5 mg of vitamin E acetate, 20 μg to 80 μg of folic acid, 10 μg to 25μg of vitamin H, and 4 mg to 10 mg of vitamin PP per unit dosage. 12.The tablet according to claim 4, wherein the vitamin is a mixture ofvitamins consisting essentially of: 0.4 mg to 0.8 mg of β-carotene, 500IU to 1500 IU of vitamin A palmitate, 0.3 mg to 1.0 mg of vitamin B₁nitrate, 0.3 mg to 1.0 mg of vitamin B₂, 0.3 mg to 1.0 mg of vitamin B₆hydrochloride, 0.4 μg to 1.0 μg of vitamin B₁₂, 15 mg to 40 mg ofvitamin C, 100 IU to 300 IU of vitamin D₃, 3.0 mg to 9.5 mg of vitamin Eacetate, 20 μg to 80 μg of folic acid, 10 μg to 25 μg of vitamin H, and4 mg to 10 mg of vitamin PP per unit dosage.
 13. The tablet according toclaim 2, wherein the mineral is selected from the group consisting of:manganese (II) gluconate, copper (II) carbonate, calcium phosphate,ferrous (II) fumarate, zinc oxide, and magnesium oxide.
 14. The tabletaccording to claim 4, wherein the mineral is selected from the groupconsisting of: manganese (II) gluconate, copper (II) carbonate, calciumphosphate, ferrous (II) fumarate, zinc oxide, and magnesium oxide. 15.The tablet according to claim 6, wherein the mineral is selected fromthe group consisting of: manganese (II) gluconate, copper (II)carbonate, calcium phosphate, ferrous (II) fumarate, zinc oxide, andmagnesium oxide.
 16. The tablet according to claim 8, wherein themineral is selected from the group consisting of: manganese (II)gluconate, copper (II) carbonate, calcium phosphate, ferrous (II)fumarate, zinc oxide, and magnesium oxide.
 17. The tablet according toclaim 10, wherein the mineral is selected from the group consisting of:manganese (II) gluconate, copper (II) carbonate, calcium phosphate,ferrous (II) fumarate, zinc oxide, and magnesium oxide.
 18. The tabletaccording to claim 12, wherein the mineral is selected from the groupconsisting of: manganese (II) gluconate, copper (II) carbonate, calciumphosphate, ferrous (II) fumarate, zinc oxide, and magnesium oxide. 19.The tablet according to claim 2, wherein the mineral is a mixture ofminerals consisting essentially of: 0.2 mg to 0.8 mg of copper (II)carbonate, 150 mg to 300 mg of dicalcium phosphate anhydrous, 8.0 mg to20 mg of ferrous (II) fumarate, 4 mg to 9 mg of zinc oxide, and 12 mg to28 mg of magnesium oxide.
 20. The tablet according to claim 4, whereinthe mineral is a mixture of minerals consisting essentially of: 0.2 mgto 0.8 mg of copper (II) carbonate, 150 mg to 300 mg of dicalciumphosphate anhydrous, 8.0 mg to 20 mg of ferrous (III) fumarate, 4 mg to9 mg of zinc oxide, and 12 mg to 28 mg of magnesium oxide.
 21. Thetablet according to claim 6, wherein the mineral is a mixture ofminerals consisting essentially of: 0.2 mg to 0.8 mg of copper (II)carbonate, 150 mg to 300 mg of dicalcium phosphate anhydrous, 8.0 mg to20 mg of ferrous (II) fumarate, 4 mg to 9 mg of zinc oxide, and 12 mg to28 mg of magnesium oxide.
 22. The tablet according to claim 8, whereinthe mineral is a mixture of minerals consisting essentially of: 0.2 mgto 0.8 mg of copper (II) carbonate, 150 mg to 300 mg of dicalciumphosphate anhydrous, 8.0 mg to 20 mg of ferrous (II) fumarate, 4 mg to 9mg of zinc oxide, and 12 mg to 28 mg of magnesium oxide.
 23. The tabletaccording to claim 10, wherein the mineral is a mixture of mineralsconsisting essentially of: 0.2 mg to 0.8 mg of copper (II) carbonate,150 mg to 300 mg of dicalcium phosphate anhydrous, 8.0 mg to 20 mg offerrous (II) fumarate, 4 mg to 9 mg of zinc oxide, and 12 mg to 28 mg ofmagnesium oxide.
 24. The tablet according to claim 12, wherein themineral is a mixture of minerals consisting essentially of: 0.2 mg to0.8 mg of copper (II) carbonate, 150 mg to 300 mg of dicalcium phosphateanhydrous, 8.0 mg to 20 mg of ferrous (II) fumarate, 4 mg to 9 mg ofzinc oxide, and 12 mg to 28 mg of magnesium oxide.
 25. The tabletaccording to claim 1, wherein lysine or a pharmaceutically acceptablesalt thereof comprises (L)-lysine monohydrochloride.
 26. The tabletaccording to one of claims 2 to 24, wherein lysine or a pharmaceuticallyacceptable salt thereof comprises (L)-lysine monohydrochloride.
 27. Thetablet according to one of claims 1 to 24, wherein lysine or apharmaceutically acceptable salt thereof consists essentially of 10 mgto 100 mg of (L)-lysine monohydrochloride.
 28. The tablet according toclaim 1, wherein the sweetener is selected from the group consisting of:calcium saccharinate, ammonium cyclamate, ammonium glycirhizinate,aspartame, glucose, and glucitols.
 29. The tablet according to claim 25,wherein the sweetener is selected from the group consisting of: calciumsaccharinate, ammonium cyclamate, ammonium glycirhizinate, aspartame,glucose, and glucitols.
 30. The tablet according to claim 3, wherein theflavoring agent is selected from the group consisting of: natural citrusor orange flavor.
 31. The tablet according to claim 4, wherein theflavoring agent is selected from the group consisting of: natural citrusor orange flavor.
 32. The tablet according to claim 3, wherein: thesweetener consists essentially of 1.0 mg to 10.0 mg of aspartame, 5.0 mgto 50.0 mg of glucose syrup, and 200 mg to 800 mg of sorbitol, and theflavoring agent comprises 5.0 mg to 50.0 mg of natural orange flavor.33. The tablet according to claim 4, wherein: the sweetener consistsessentially of 1.0 mg to 10.0 mg of aspartame, 5.0 mg to 50.0 mg ofglucose syrup, and 200 mg to 800 mg of sorbitol, and the flavoring agentcomprises 5.0 mg to 50.0 mg of natural orange flavor.
 34. The tabletaccording to claim 1, wherein a pharmaceutically or dieteticallyacceptable carrier is selected from the group consisting of: diluents,excipients, sticking agents, buffering agents, bulk agents, lubricatingagents, and colorants.
 35. A tablet comprising: (a) a mixture ofvitamins consisting essentially of: 0.4 mg to 0.8 mg of β-carotene, 500IU to 1500 IU of vitamin A palmitate, 0.3 mg to 1.0 mg of vitamin B₁nitrate, 0.3 mg to 1.0 mg of vitamin B₂, 0.3 mg to 1.0 mg of vitamin B₆hydrochloride, 0.4 μg to 1.0 μg of vitamin B₁₂, 15 mg to 40 mg ofvitamin C, 100 IU to 300 IU of vitamin D₃, 3.0 mg to 9.5 mg of vitamin Eacetate, 20 g to 80 μg of folic acid, 10 to 25 μg of vitamin H, and 4 mgto 10 mg of vitamin PP, ( b) a mixture of minerals consistingessentially of 0.2 mg to 0.8 mg of copper (IU) carbonate, 150 mg to 300mg of dicalcium phosphate anhydrous, 8.0 mg to 20 mg of ferrous (II)fumarate, 4 mg to 9 mg of zinc oxide and 12 mg to 28 mg of magnesiumoxide, (c) 10 mg to 100 mg of (L)-lysine monohydrochloride per unitdosage, (d) a mixture of sweeteners and flavoring agents comprising: 1.0mg to 10.0 mg of aspartame, 5.0 mg to 50.0 mg of glucose syrup, 200 mgto 800 mg of sorbitol, and 5.0 mg to 50.0 mg of natural orange flavor;(e) a pharmaceutically or dietetically acceptable carrier, wherein thetablet weighs 500 mg to 2000 mg.
 36. A method of improving thephysiological state of a human comprising administering orally to thehuman an effective amount of a tablet which can be chewed or suckedcomprising: (a) a vitamin; (b) lysine or a pharmaceutically acceptablesalt thereof; (c) a sweetener; and (d) a pharmaceutically ordietetically acceptable carrier.
 37. The method according to claim 36,wherein the tablet further comprises a mineral.
 38. The method accordingto claim 36, wherein the tablet further comprises a flavoring agentcapable of masking the flavor of lysine.
 39. The method according toclaim 37, wherein the tablet further comprises a flavoring agent capableof masking the flavor of lysine.
 40. A method of improving thedevelopment and growth of a child or juvenile comprising administeringorally to the child or juvenile an effective amount of a tablet whichcan be chewed or sucked comprising: (a) a vitamin; (b) lysine or apharmaceutically acceptable salt thereof; (c) a sweetener; and (d) apharmaceutically or dietetically acceptable carrier.
 41. The methodaccording to claim 40, wherein the tablet further comprises a mineral.42. The method according to claim 40, wherein the tablet furthercomprises a flavoring agent capable of masking the flavor of lysine. 43.The method according to claim 41, wherein the tablet further comprises aflavoring agent capable of masking the flavor of lysine.